VIVUS Initiates Open Label Safety Study of Avanafil for Erectile D...( Enrollment in First Pivotal Phase 3 A...),Health

Enrollment in First Pivotal Phase 3 Avanafil Study REVIVE (TA-301) is Complete

MOUNTAIN VIEW, Calif., May 13 /PRNewswire-FirstCall/ -- VIVUS, Inc. (Nasdaq: VVUS), a biopharmaceutical company developing innovative, next-generation therapies to address unmet needs in obesity, diabetes and sexual health, today announced that it has initiated an open label safety study (TA-314) with its investigational drug, avanafil, in males with erectile dysfunction (ED).

VIVUS also announced today that it has completed enrollment in REVIVE (TA-301), a randomized, double-blind, placebo-controlled phase 3 study of avanafil in men with a history of generalized ED and the first of several planned phase 3 studies of avanafil. Approximately 650 patients have been enrolled in the study. Top-line results of REVIVE are expected in the fourth quarter of 2009.

Avanafil, a next-generation, fast-acting, selective, oral, phosphodiesterase type 5 (PDE5) inhibitor, is VIVUS' investigational product for the treatment of ED. The phase 3 program for avanafil is funded through a $30 million collaboration with Deerfield Management.

"We continue to make excellent progress on the avanafil phase 3 program, and are pleased with the rapid rate at which we accrued patients in our first pivotal study, REVIVE," commented Charles Bowden, MD, senior director of clinical development at VIVUS. "Initiation of the TA-314 safety study is a critical step in advancing avanafil toward an NDA filing. We are confident that avanafil will provide a much needed new option for the millions of men living with ED, and we look forward to announcing data from both of these studies later this year and next."

The open-label study is being conducted in approximately 600 patients across 40 U.S. centers. Patients completing either the 12-week REVIVE or R
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